Flemish Inguinal and Femoral Hernia Prospective Registry

Overview

Prospective registry. The purpose of this clinical trial will be to measure surgical outcome parameters (e.g. recurrence, chronic pain and other quality indicators) after inguinal hernia repair using Patient Reported Outcome Measures (PROMs) in the short- and long-term.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 31, 2022

Detailed Description

The primary objective is to investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities. The secondary objectives are: – Surgical Site Occurrence (SSO) after 30 days – Scope and incidence of pre- and postoperative pain (NRS 0 to 10) – The difference between pre- and postoperative NRS scores (relative NRS score) – Presence of pain and impact of pain on daily life activities – Satisfaction and quality of life – Sexual function – Anxiety and depression – Catastrophizing – Recurrence – Development of a predictive model for chronic pain.

Interventions

  • Device: Surgical inguinal or femoral hernia repair
    • Surgical inguinal or femoral hernia repair (primary or mesh)

Arms, Groups and Cohorts

  • Inguinal or femoral hernia repair
    • All consecutive inguinal or femoral hernia repair (primary or mesh)

Clinical Trial Outcome Measures

Primary Measures

  • Chronic pain after inguinal hernia repair
    • Time Frame: 5 years
    • To investigate moderate to severe chronic pain 1 year after inguinal or femoral hernia repair, defined as numeric rating scale (NRS) ≥ 4, during daily activities.

Participating in This Clinical Trial

Inclusion criteria

  • Consecutively all patients with a groin hernia (inguinal and/or femoral hernia) operated starting 01.01.2018. – Male and female – 18 years or older – Operated of supervised by a participating surgeon (participating in this study is not necessarily by a whole surgical department of a hospital, but by specific surgeons) – Elective and emergency surgery – Primary and recurrent hernia – Metachronous and synchronous hernia – Signed informed consent form Exclusion criteria – Younger than 18 years – Not operated or supervised by participating surgeon – Pregnant at inclusion in the registry – No signed informed consent form

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitaire Ziekenhuizen Leuven
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Colette Ms. Barlé, ++32 16 341699, colette.barle@uzleuven.be

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